R&D Quality Assurance Strategic Performance and Operations Director

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

R&D Quality Assurance Strategic Performance and Operations Director

What you will do

Lets do this! Lets change the world!

This leadership role in Research and Development Quality Assurance (RDQ) supports Research & Development and the Office of the Chief Medical Office and Regulatory Affairs serving as a member of the RDQ leadership Team, reporting to the Vice President (VP) of RDQ. The Director of RDQ Strategic Performance and Operations is responsible for managing the day to day operations of supporting our growing team including: supporting and helping drive RDQ transformation and advancement including: ways of working, build of quality analytics, advancing risk assessments, quality metric trending and driving performance management. Additionally, driving organization of key RDQ meetings including RDQ Leadership, All Staff and Group Meetings. Driving/tracking progress of continuous improvement and process simplification and optimization, digital, data structure build & analytics and technology processes and solutions. Candidates must possess experience in effective decision making, influencing skills, and ability to simultaneously manage numerous complex issues and projects. This position requires demonstration of strong management and leadership skills along with advanced communication and analytical skills.

Change the Business - strategy and initiatives:

• Partner with RDQ LT to agree to priorities, quantitate opportunities that support the overall RDQ and Global Quality strategies

• Develop the concept for change and advancement to a deployable strategy identifying and quantitating opportunities to simplifying processes, removing non-value added activities and drive value for Amgen

Transformation and Continuous Improvement:

• Working with RDQ LT and their direct reports to drive and track RDQ transformation and continued advancement (people process and technology)

• Support the build of new ways of working tools that drive/advance simplicity, connectivity and insights that are scalable to the business needs

• Support new technology development

Risk management/work prioritization:

• Support build and drive of risk assessment and risk prioritization of RDQ work, supporting effectively the management of resources, driving what we spend time on and what we do not

• Drive provisional status decision making process as it relates to RDQ people, processes, technologies

Chief of Staff:

• Ensure on time delivery of any action items and commitments

• Develop advance and implement RDQ communication strategy

• Build VP and appropriate RDQ LT presentations

• Responsible for regular RDQ LT meetings. This includes coordinating agenda topics, consolidating presentation and pre-read content, distributing pre-reads, facilitating each meeting, and creating/distributing minutes and follow up on action items

• Partner with HR Business Partner to support talent management meetings, staffing/organizational initiatives as deemed necessary, and organizational or workforce strategy related efforts

• Partner with RDQ, finance lead to educate on and translate functional priorities and business details related to financials. Partner on data and visualization appropriate for audience and oversight of organizational shape and budget. Review financials monthly with leadership team

• Responsible for planning, developing, and maintaining the RDQ budget

• Coordination and oversight of organizational deliverables, annual goals, and management of the overall RDQ initiatives

• Build strong relationships with RDQ Customers

Management Reviews, Trending and QS and Quality Performance:

• Work with RDQ to monitor the key quality performance and key quality indicators for the organization.

• Where quality KPI performance is not meeting targets, support the ES/ESQ teams to develop a plan for improvement of the metric with the key partners involved.

Leadership responsibilities:

• Requires clarity of decision making and authority at all levels and driving diligence on prioritization cross functionally

• Developing and implementing objectives and business strategies

• Selecting key personnel and motivating members of the functional area

• Challenging employees to develop as leaders while serving as a role model and mentor

• Training and development

• Supporting workforce diversity, quality and safety, supporting supervisors/managers in the management of their employees/department which support achievement of individual/department/business objectives

• Ensuring compliance with all regulatory requirements and Amgen policies and practices

• Establishing departmental and individual goals and objectives in alignment with Global Quality and ES goals and priorities

• Identifying performance improvement targets and metrics

• Ensuring capabilities and capacity in place to effectively deliver on all departmental commitments and performance targets

• Strengthening overall leadership and organizational capabilities in area of responsibility

• Building and sustaining high performance management team and ensuring strong alignment and coordination with other functional groups

• Identifying the required resources and expertise, implementing the appropriate team/departmental structures and establishing the required processes and communications to enable department(s) to effectively deliver on all commitments while building a culture of Safety and Quality and continuous improvement

• Ensuring effective utilization of resources by ensuring robust employee development, performance management, succession planning, and rewards and recognitions practices in area of responsibility

• Building and sustaining employee engagement by creating an environment within which individuals and teams can excel

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

• Doctorate degree and 4 years of quality assurance experience OR

• Masters degree and 8 years of quality assurance experience OR

• Bachelors degree and 10 years of qualify assurance experience

In addition to meeting at least one of the above requirements, you must have at least 4 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

• Significant experience in biotechnology, leading development, and execution of cross functional, complex technical projects

• Direct experience partnering with and influencing executive leadership

• Continuous improvement / Lean transformation experience

• Excellent oral and written communication skills and executive presence, including ability to storyline and prepare executive-level presentations and pre-reads

• Adapting and thriving in a rapidly changing and fast-moving environment

• Strong leadership skills with a demonstrated ability to influence different functions and levels of the organization

• Excellent project management skills with the ability to lead effectively in a matrixed, highly fluid environment

• Ability to foster collaboration, work effectively on cross-functional teams and consistently deliver on-time while serving as a role model for Amgen values and leadership attributes

• Strong knowledge of relevant quality system elements and GxPs

• Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs

• Excellent communication skills able to work with and influence executive management. Ability to gather disparate information and develop into executive ready materials

• Direct experience in a cross-functional business operations or strategic project management role

• Deep understanding of R&D, ATMOS and Office of the Chief Medical Officer organizations

• Highly organized with a demonstrated ability to build and maintain strong relationships with team members and supporting functions (e.g. R&D, ATMOS, OCMO, Human Resources, Finance)

• Strong financial foresight and ability to interpret and communicate financial information

• BSc in science, engineering or equivalent with additionally qualifications (Masters /PhD)

• Significant experience in transformational change programs. Experience in the development and rolling out of effective training programs

• Awareness and understanding of quality and regulatory industry trends, policies and guidelines

• Proven skills in building and maintaining productive relationships

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.